Recall Z-0551-2019— Capintec Inc
Class II · Terminated
Class II FDA medical device recall by Capintec Inc, initiated 2018-11-05, terminated 2020-06-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138. Reason: There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its lowest point of travel, approximately 25 inches from the ground..
- Recalling firm
- Capintec Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-05
- Terminated
- 2020-06-30
- Firm location
- Florham Park, NJ, United States
Product description
Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
Reason for recall
There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its lowest point of travel, approximately 25 inches from the ground.
Data sourced from openFDA. This site is unofficial and independent of the FDA.